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Background: There is growing evidence that performing a radical intravelar veloplasty (IVV) improves speech outcomes. The aim of this study was to determine the impact of a radical IVV during primary palatoplasty on the rate of secondary speech surgery., Methods: This is a retrospective review of primary palatoplasty using an IVV performed by a single surgeon from the year 2000 to 2023. In 2008, the surgeon changed technique to involve a more radical IVV. The radical overlapping IVV involves release of the palatopharyngeus from the posterior hard palate and from the nasal component of the tensor veli palatini, release of the levator veli palatini to the levator tunnel, and overlapping of the palatopharyngeus-levator unit across the midline after retro-positioning. This separated the patients into a before and after technique change group. The rate of secondary speech surgery was compared between the two time periods., Results: An IVV was performed during straight line repairs 333 and 272 times during the first and second time periods, respectively. The second radical overlapping IVV group had significantly (p<0.05) less secondary speech surgery procedures at 43 (15.81%) compared to 83 (24.92%) amongst the first conservative IVV group (p<0.05)., Conclusions: Precise anatomical dissection, extensive release, retro-positioning and overlap of the velar musculature during IVV results in significantly less secondary speech surgery., (Copyright © 2024 by the American Society of Plastic Surgeons.)

Introduction: Cleft alveolar bone graft surgery is technically challenging to perform as well as difficult to learn and teach. A high-fidelity cleft alveolar bone graft simulator was previously developed. However, further evaluation of the simulator is necessary to assess its efficacy., Methods: Two cleft simulation workshops were conducted in which participants were led through a simulated cleft alveolar bone graft. The first simulation workshop involved six plastic surgery trainees. The second workshop involved 43 practicing cleft surgeons. The participants were provided with a Likert-type questionnaire assessing the simulators' features, realism, and value as a training tool. The change in self-reported confidence was assessed by providing each participant with a pre- and post-simulation confidence questionnaire., Results: There was overall agreement in the realism of the simulators' features (average score of 4.67 and 3.80 out of 5 for the trainees and surgeons, respectively). There was overall agreement to strong agreement in the simulators value as a training tool (average score of 5 and 4.43 out of 5 for the trainees and surgeons, respectively). The self-reported confidence increased for all questionnaire items for both the trainees and surgeons. This was significant (p < 0.05) for five out of eight and all questionnaire items for the trainees and surgeons, respectively. The magnitude of the confidence increase was generally greater for less experienced participants., Conclusion: The cleft alveolar bone graft simulator was found to be realistic and valuable as a training platform. Use of the simulator improved self-reported confidence in cleft alveolar bone graft surgery., (Copyright © 2024 British Association of Plastic, Reconstructive and Aesthetic Surgeons. All rights reserved.)

Objective: To evaluate the features, anatomic accuracy, and educational value of a high-fidelity bilateral cleft lip simulator., Design: Evaluation of the simulator by expert cleft surgeons after performing a simulated bilateral cleft lip repair., Setting: The simulator was evaluated by the surgeons during the Latin American Craniofacial Association meeting., Participants: Eleven experienced cleft surgeons evaluated the simulator. The cleft surgeons were selected based on their availability during the meeting., Interventions: The participants performed a simulated bilateral cleft lip repair. They were each provided with a questionnaire assessing the simulator's features, realism and value as a training tool., Main Outcome Measure (s): The main outcome measure are the scores obtained from a Likert-type questionnaire assessing the simulators features, realism and value., Results: Overall, the surgeons agreed with the simulator's realism and anatomic accuracy (average score of 3.7 out of 5). Overall, the surgeons strongly agreed with the value of the simulator as a training tool (average score of 4.6 out of 5)., Conclusions: A high-fidelity bilateral cleft lip simulator was developed that is realistic and valuable as a training tool. The simulator provides a comprehensive training platform to gain hands-on experience in bilateral cleft lip repair before operating on real patients., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: There is currently a lack of patient-reported outcome measures for ear reconstruction. We developed the EAR-Q to measure ear appearance and post-operative adverse effects from the patient perspective., Methods: Field-test data were collected from children and young adults in eight countries between 13 May 2016 and 12 December 2019. Rasch measurement theory (RMT) analysis was used to refine the scales and to examine their psychometric properties., Results: Participants had microtia (n = 607), prominent ears (n = 145) or another ear condition (n = 111), and provided 960 assessments for the Appearance scale (e.g., size, shape, photos), and 137 assessments for the Adverse Effects scale (e.g., itchy, painful, numb). RMT analysis led to the reduction of each scale to 10-items. Data fit the Rasch model for the Appearance (X 2 (80) = 90.9, p = 0.19) and Adverse Effects (X 2 (20) = 24.5, p = 0.22) scales. All items in each scale had ordered thresholds and good item fit. There was no evidence of differential item function for the Appearance scale by age, gender, language, or type of ear condition. Reliability was high for the Appearance scale, with person separation index (PSI) and Cronbach alpha values with and without extremes ≥0.92. Reliability for the Adverse Effects scale was adequate (i.e., PSI and Cronbach alpha values ≥0.71). Higher scores (liked appearance more) correlated with higher scores (better) on Psychological, Social and School scales., Interpretation: The EAR-Q can be used in those 8-29 years of age to understand the patient perspective in clinical practice and research, and in addition, can be used to benchmark outcomes for ear reconstruction internationally., Competing Interests: Declaration of Competing Interest The EAR-Q is owned by McMaster University and the Hospital for Sick Children. Drs Anne Klassen and Karen Wong Riff co-developed the EAR-Q and receive a share of any license revenues as royalties based on their institutions’ inventor sharing policy. The other authors do not have conflicts of interest related to this study., (Copyright © 2021. Published by Elsevier Ltd.)

Background: The CLEFT-Q includes 12 independently functioning scales that measure appearance (face, nose, nostrils, teeth, lips, jaws), health-related quality of life (psychological, social, school, speech distress), and speech function, and an eating/drinking checklist. Previous qualitative research revealed that the CLEFT-Q has content validity in noncleft craniofacial conditions. This study aimed to examine the psychometric performance of the CLEFT-Q in an international sample of patients with a broad range of facial conditions., Methods: Data were collected between October 2016 and December 2019 from 2132 patients aged 8 to 29 years with noncleft facial conditions. Rasch measurement theory (RMT) analysis was used to examine Differential Item Function (DIF) by comparing the original CLEFT-Q sample and the new FACE-Q craniofacial sample. Reliability and validity of the scales in a combined cleft and craniofacial sample (n=4743) were examined., Results: DIF was found for 23 CLEFT-Q items when the datasets for the two samples were compared. When items with DIF were split by sample, correlations between the original and split person locations showed that DIF had negligible impact on scale scoring (correlations ≥0.995). In the combined sample, RMT analysis led to the retention of original content for ten CLEFT-Q scales, modification of the Teeth scale, and the addition of an Eating/Drinking scale. Data obtained fit with the Rasch model for 11 scales (exception School, p=0.04). Person Separation Index and Cronbach alpha values met the criteria., Conclusion: The scales described in this study can be used to measure outcomes in children and young adults with cleft and noncleft craniofacial conditions., Competing Interests: Conflict of Interest Statement Anne Klassen and Karen Wong are co-developers of the patient-reported outcome scales described in this publication and receive a share of any license revenues as royalties based on their institutions’ inventor sharing policy for their use in for-profit study. The other authors have no conflicts of interest to declare in relation to the content of this article., (Copyright © 2021 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.)

Objective: The objectives of this study were to assess economy of hand motion of residents, fellows, and staff surgeons using a high-fidelity cleft palate simulator to (1) stratify performance for the purpose of simulator validation and (2) to estimate the learning curve., Design: Two residents, 2 fellows, and 2 staff surgeons performed cleft palate surgery on a high-fidelity cleft palate simulator while their hand motion was tracked using an electromagnetic hand sensor. The time, number of hand movements, and path length of their hands were determined for 10 steps of the procedure. The magnitude of these metrics was compared among the 3 groups of participants and utilized to estimate the learning curve using curve-fitting analysis., Results: The residents required the most time, number of hand movements, and path length to complete the procedure. Although the number of hand movements was closely matched between the fellows and staff, the overall total path length was shorter for the staff. Inverse curves were fit to the data to represent the learning curve and 25 and 113 simulation sessions are required to reach within 5% and 1% of the expert level, respectively., Conclusion: The simulator successfully stratified performance using economy of hand motion. Path length is better matched to previous level of experience compared to time or number of hand movements.

Background: Cleft lip surgery is technically difficult requiring precise planning and understanding of 3-dimensional structures to obtain an optimal outcome. A physical cleft lip simulator was developed that allows trainees to gain experience in cleft lip repair and primary rhinoplasty before operating on real patients., Methods: A cleft lip simulator that comprises multilayered soft tissues, bone, and realistic dissection planes was developed using 3D printing, adhesive and polymer techniques. Four experienced cleft surgeons performed a total of 7 simulated repairs on the simulator. Feedback on the realism and value of the simulator was obtained from the surgeons., Results: Six of the repairs were a Fisher anatomic subunit approximation technique, and 1 was a rotation advancement repair. All repairs were completed with successful performance of markings, incisions, dissections, and multilayered closure. All surgeons agreed that the simulator is realistic and that the simulator is a valuable tool for training in cleft lip surgery., Conclusions: A cleft lip simulator that allows performance of a cleft lip repair and primary rhinoplasty from start to finish was developed and pilot tested. The simulator provides a training platform to gain experience in cleft lip repair before operating on real patients.

Background: This study assessed technical performance in cleft palate repair using a newly developed assessment tool and high-fidelity cleft palate simulator through a longitudinal simulation training exercise., Methods: Three residents performed five and one resident performed nine consecutive endoscopically recorded cleft palate repairs using a cleft palate simulator. Two fellows in pediatric plastic surgery and two expert cleft surgeons also performed recorded simulated repairs. The Cleft Palate Objective Structured Assessment of Technical Skill (CLOSATS) and end-product scales were developed to assess performance. Two blinded cleft surgeons assessed the recordings and the final repairs using the CLOSATS, end-product scale, and a previously developed global rating scale., Results: The average procedure-specific (CLOSATS), global rating, and end-product scores increased logarithmically after each successive simulation session for the residents. Reliability of the CLOSATS (average item intraclass correlation coefficient (ICC), 0.85 ± 0.093) and global ratings (average item ICC, 0.91 ± 0.02) among the raters was high. Reliability of the end-product assessments was lower (average item ICC, 0.66 ± 0.15). Standard setting linear regression using an overall cutoff score of 7 of 10 corresponded to a pass score for the CLOSATS and the global score of 44 (maximum, 60) and 23 (maximum, 30), respectively. Using logarithmic best-fit curves, 6.3 simulation sessions are required to reach the minimum standard., Conclusions: A high-fidelity cleft palate simulator has been developed that improves technical performance in cleft palate repair. The simulator and technical assessment scores can be used to determine performance before operating on patients.

Introduction: Patient-reported outcome (PRO) instruments should be developed according to rigorous guidelines in order to provide clinically meaningful, scientifically sound measurement. Understanding the methodology behind instrument development informs the selection of the most appropriate tool. This mixed methods protocol describes the development of an internationally applicable PRO instrument, the CLEFT-Q, for evaluating outcomes of treatment for cleft lip and/or palate (CL/P)., Methods and Analysis: The study includes three main phases that occur iteratively and interactively. In phase I, we determine what concepts are important to patients regarding their outcome. A conceptual framework for the CLEFT-Q is formed through a systematic review and an extensive international qualitative study. The systematic review ascertains what concepts have previously been measured in patients with CL/P. The qualitative study employs interpretive description and involves in-depth interviews with patients in high-income and lower-middle income countries. Preliminary items are generated from the qualitative data. Preliminary scales are then created for each theme in the framework. Cognitive debriefing interviews and expert clinician input are used to refine the scales in an iterative process. In phase II, the preliminary scales are administered to a large international group of patients with CL/P. The modern psychometric method of Rasch Measurement Theory analysis is employed to define the measurement characteristics. The preliminary scales are shortened based on these results. In phase III, further tests assess reliability, validity and responsiveness of the instrument., Ethics and Dissemination: The study is approved by Research Ethics Boards for each participating site. Findings from this study will be published in open access peer-reviewed journals and presented at national and international conferences. Integrated knowledge translation is employed to engage stakeholders from the outset of the study. Successful execution of the CLEFT-Q will result in an internationally applicable PRO instrument for children and young adults with CL/P., Competing Interests: KWYWR, ET, TG, CRF, ALP and AFK declare that they have no competing interests. SJC started Modus Outcomes, a company that designs PRO instruments, after the inception of this study., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)